White Coat Underground

DSHEA: a travesty of a mockery of a sham

In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA). This act allows for the marketing and sales of “dietary supplements” with little or no regulation. This act is the work of folks like Tom Harkin (who took large contributions from Herbalife) and Orrin Hatch, whose state of Utah is home to many supplement companies.

DSHEA has a couple of very important consequences (aside from filling the pockets of supplement makers).

What does the FDA require of “supplements”?

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.

To paraphrase: “sell whatever you want, just don’t let us catch you.”

What’s more frightening than this inexcusable lack of oversight is that many of the products marketed under DSHEA aren’t just vitamins and such, but products that claim to do the same things as real medicines. How do they get away with that?

By using the Quack Miranda Warning, that’s how. Anyone who lives in the States knows this one almost as well as the “real” Miranda warning:

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

I put in the asterisk because there’s always an asterisk. The warning always appears at the bottom of a back page in very fine print. This statement is required when making any clinical claims regarding a product, and it is up to the manufacturer to make sure all claims are true.

Here’s the thing: many products covered by DSHEA are, by their advertising, clearly “intended to diagnose, treat, cure or prevent…disease.”

Googling the warning itself is a great way to hunt for quackery. I did just such a search recently and came up with PectaSol. It’s hard to tell from the ad who exactly is making these claims: the maker of the product, the online store selling it, or both. Either way, here are some of the claims:

  • enhance your immune system function, especially if you have a chronic disease
  • maintain your optimal health by removing toxic and radioactive metals in your body
  • slow down the doubling time of your PSA (male prostate) levels when cancer is present
  • help prevent aberrant cells from adhering to your critical organs and tissues like the prostate, breast, colon, lymphatic system, skin, brain and larynx
  • promote normal cholesterol levels
  • take a supplement that has been successfully clinically tested
  • shown to reduce your total body burden of toxicity from Mercury by up to 70% in six months when consuming 15 grams of PectaSol per day

If you follow the link that purports to support their claim of “clinically tested”, a blank page is all you get.

Clearly, they are claiming to treat or prevent disease. What else could they mean by their claim about PSA or their claim about cholesterol? These statements may or may not adhere to the letter of the law, but what concerns me more is their adherence to the spirit of the law. DSHEA was created specifically to allow these companies to make claims that would otherwise be of questionable legality. DSHEA, as it was written and as it was intended facilitates the legal marketing of quackery.

This legislation must go. It’s dangerous and costly for consumers, and provides protection for business entities whose apparent purpose is to promote quackery for profit. The lawmakers behind this bill should be ashamed.

Comments

  1. #1 katydid13
    July 20, 2009

    In 1997 or there abouts, the Senate made what some people thought were noises about changing this (I’m not even sure there was actually an effort to change it underway, I just know that someone thought there might be changes), I was early in my career and answering phones in senator’s office. This generated more phone traffic than any other issue at the same time. I mean any issue. Abortion, gay rights, taxes, foreign policy or whatever you could name. Someone organized the people who sold this stuff, who organized their customers who then proceed to call the office and yell at me about how Congress was going to take their vitamins and supplements away and somehow in the process kill Grandma. They all seemed to be a little crazy and very motivated. Don’t under estimate their level of organization.

  2. #2 Jared
    July 20, 2009

    Another few good phrases to catch quackery:
    “boost your immune system”
    “doctors won’t tell you”
    “it worked for me”
    “miracle cure”
    “my x was cured in y days”–substitute x and y with any numbers.

    You can also use this nifty little website:
    http://www.quackometer.net/

    Here’s another website for PectaSol
    http://www.naturalhealthconsult.com/Monographs/PectaSolChelation.html
    The quackometer read “9″ on the one you posted and “!” for this one.

  3. #3 Jeff
    July 20, 2009

    1. PalMD states that PectaSol claims to slow down the doubling time of your PSA (male prostate) levels when cancer is present.

    PectaSol is Modified Citrus Pectin. Supplement companies are allowed to quote from the scientific literature. Several clinical studies have shown that MCP can slow down the doubling time of PSA: http://www.medicalnewstoday.com/articles/82455.php

    “The analysis of these studies suggests that MCP is beneficial in the treatment of prostate cancer”, commented Dr. Eliaz. “The exciting aspect of using modified citrus pectin is that it is a safe, nontoxic natural product, which is a real concern for cancer patients. So safety and efficacy are two important elements in the use of MCP in
    prostate cancer patients, as well as in patients with other kinds of cancer.”

    2. PalMD: To paraphrase: “sell whatever you want, just don’t let us catch you.” Really?

    All new supplement ingredients since 1994 must submit a formal 75-day notice along with evidence that a new product is reasonably expected to be safe. This is called the new dietary ingredient notification (NDI). If the FDA has concerns about the ingredient or its safety profile, the agency has clear authority to request more information or to reject the notification and deny the product’s entry into the market. Since the passage of DSHEA the FDA has REJECTED APPROXIMATELY 70% of the NDI notifications filed.

    Then there are the new, stringent General Manufacturing Practices (GMP) standards, finalized in 2007 and currently being implemented. “Dietary supplement GMPs include thorough requirements for identity testing for all ingredients as they arrive at the manufacturer’s site. Manufacturers must qualify their suppliers before receiving goods, incoming ingredients must be quarantined until their identity is confirmed using scientifically valid methods of analysis, and all components of dietary supplements must meet specifications established by the manufacturer regardless of where the ingredient was sourced. Manufacturers are accountable to the FDA for the manufacturing process as well as the ingredients. During an inspection, the FDA has access to all manufacturer’s records, including those pertaining to country of origin, for all ingredients. The existing bioterrorism law already requires all parties in production and distribution to keep records of suppliers and customers that permit the agency to trace the pedigree of ingredients back to their original source. Ia addition, the GMP rules allow FDA examination of sanitation, batch records for production, employee training, validation of manufacturing procedures, and testing of final products for conformance with the label.”

    The FDA has made it clear it will come down hard on those firms that don’t comply with the GMP standards:
    http://www.nutraingredients-usa.com/On-your-radar/Quality-control/FDA-gets-tough-on-GMP-failures

    3. There is also the FDA’s new mandatory Adverse Event Reporting system for dietary supplement companies. The numbers came in much lower than the industry’s critics expected: In 2008 the FDA received 1,080 AERs relating to supplements, compared to 526,000 AERs relating to drugs and biologic products. The new GMP standards should make a safe industry even safer.

    Does this sound like an industry with “little or no regulation”, as PalMD states?

    What DSHEA does is allow freedom of choice for American consumers. We can research the scientific literature and then decide what to put in own bodies.

  4. #4 G Felis
    July 21, 2009

    1. Gee, Jeff. Never mind the quality of the supposed evidence you cite: I’ll assume it’s perfectly legit (although I strongly doubt that is even remotely the case). That still leaves ALL THOSE OTHER UNSUPPORTED (and in some cases, so vague and bullshit-laden as to be insupportable) HEALTH CLAIMS!

    2. The NDI simply requires that manufacturers don’t put anything in their products that (1) is already known or suspected to be dangerous or (2) has a completely unknown toxicity profile. If 70% of those NDI’s have been rejected, that just indicates what kind of crazy crap supplement manufacturers try to put into products. That doesn’t speak any better of the ethics of the supplement industry than the bogus health claims. Nor does it say anything about the level of actual oversight, enforcement, and compliance with this regulation.

    And the GMP is by your own admission a recent addition – 2007, 13 years after DHEA was passed. And why was the GMP passed? Why was further regulation needed if DHEA is so brilliant? The GMP regulations were required because so many contaminated supplements produced and sold by unethical supplement manufacturers with no interest in health or safety were causing serious health problems in consumers. And as far as I know, GMP has been – like almost everything at the FDA for the past 8 years or so – a largely unfunded (or at least massively underfunded) mandate. How many inspectors are there? How many manufacturers? I bet those numbers don’t compare well. Regulation without meaningful enforcement does not have any real impact.

    3. It is well known that a large proportion of AER’s are generated by the reverse placebo effect: People who read the side effect literature that comes with their medication experience the side effects they read about in significantly greater proportion than those who do not read the literature. Supplements do not come with side effect literature, just overstated and unsupported health claims (with a small print quack miranda warning). Furthermore, the long-standing drug AER system has significantly more history and enforcement – and gets vastly more cooperation from pharmaceutical companies – than the brand-spanking-new supplement AERs.

    And again, note that this law was passed 15 years after DHEA, and was only required because of problems CAUSED by DHEA. No DHEA, no problem to be solved by additional regulations and enforcement expenditures.

    2 & 3 combined don’t look very good for your case, Jeff. All the real oversight regulation followed DHEA by a decade-and-a-half, and that additional regulation was motivated by problems that only arose in the first place because of DHEA’s flawed (I’ll phrase it more strongly than PalMD) “sell whatever you want and we’ll (maybe) catch you if you kill some people” approach to (non-)regulation. No DHEA, no problems that had to be resolved by later regulation. So why not kill or heavily modify DHEA as the bad legislation it always was, and still is?

    Oh, right. The all-trumping argument of consumer choice! What’s that, 4 of diamonds in the Denialists’ Deck of Cards? Come to think of it, I could’ve saved some electrons by just pointing to the deck in the first place in lieu of going over your supplement industry talking points one at a time. Everything you said is represented somewhere in the deck.

  5. #5 Jeff
    July 21, 2009

    Felis: The GMP standards were provided for in the original DSHEA bill in 1994. It was left up to the FDA to come up with a specific set of rules and apply them to the supplement industry. For reasons not clear (apathy?) the FDA waited 13 years to finalize the GMP rules. Most supplement makers are glad to see them enforced, because it gives the FDA a tool to rid the marketplace of rogue players (yes, every industry has them). Most of the dishonest claims come from the weight loss segment of the industry. The FDA recently made it clear it will use its legal authority to force weight loss products from making unrealistic claims.

    “Sell whatever you want and we’ll (maybe) catch you if you kill some people approach to (non-)regulation”. So where are the bodies? The American Association of Poison Control Centers has been collecting data on supplements for many years. In 2007 the AAPCC reports a grand total of three deaths related to all catagories of dietary supplements: vitamins, minerals, and herbal preparations. Not a bad number considering billions of bottles of supplements are sold annually. During that same year (2007) The AAPCC reports 225 deaths related to pharmaceuticals. The 2008 data hasn’t been released yet.

    Felis states: “The GMP regulations were required because so many contaminated supplements produced and sold by unethical supplement manufacturers with no interest in health or safety were causing serious health problems in consumers.” What numbers can you provide to back up that statement? Without real proof critics of the supplement industry keep repeating ad nauseum that “so many contaminated supplements are produced and sold by unethical supplement manufacturers”. I think they’re hoping that, if repeated often enough, these unsupported claims will become accepted as truth.

  6. #6 Jimbo Jones
    July 21, 2009

    @Jeff, 2
    It doesn’t matter whether or not the claims are true.

    The phrase “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” combined with any claims of improving health or preventing disease make a lie of one claim or another.

  7. #7 Jeff
    July 21, 2009

    Jimbo Jones: The disclaimer has to be posted EVEN IF the FDA accepts any health claim.

    “When describing a dietary supplement’s benefits, the law permits products to use certain claims, provided there is
    appropriate scientific support. The FDCA allows products to make structure/function claims, and health claims.
    Structure/function claims describe effects of the product on the body. However, the law requires these claims
    must have substantiation (i.e., scientific support) that the claim is truthful and not misleading; FDA must be
    informed of these claims; and it may request to review the substantiation. A disclaimer must be added to a
    product’s label stating that the structure/function claim “has not been evaluated by” FDA. Health claims describe the relationship between a substance and a disease (e.g., folic acid can reduce the risk of neural tube birth defects). These claims must be submitted to and approved by FDA and be supported by “significant scientific
    agreement.” FDA has approved a handful of health claims for key ingredients like calcium and vitamin D, folic
    acid, and psyllium (fiber). FDA may also consider granting qualified health claims when there is some evidence
    of a health benefit, but not complete scientific agreement, if qualifying language can be developed that truthfully describes the state of the evidence.”

  8. #8 Dianne
    July 21, 2009

    Speaking of herbalife, a disturbingly large number of cytopenic patients I’ve seen recently have been taking Herbalife. I’m not sure if this is even a real correlation, having no idea what percentage of the general public takes Herbalife, much less whether there is a causal connection, but am starting to worry. Pal, have you seen this?

  9. #9 catgirl
    July 21, 2009

    I have to take iron supplements to prevent anemia, but I am always a little concerned that I’m getting something bad along with it. I would feel much safer if I knew the FDA was looking out for me with these things.

  10. #10 Stu
    July 21, 2009

    What DSHEA does is allow freedom of choice for American consumers. We can research the scientific literature and then decide what to put in own bodies.

    Hello, stooge. I do hope you’re getting paid for this.

  11. #11 Calli Arcale
    July 21, 2009

    Jeff:

    What DSHEA does is allow freedom of choice for American consumers. We can research the scientific literature and then decide what to put in own bodies.

    What exactly prevented you from educating yourself before DSHEA? And how is it helpful to “freedom” that DSHEA makes it possible to market drugs with less information about their safety, no required information about efficacy, and no requirement that they standardize their formulations?

    I would contend that DSHEA has actually *reduced* health freedom, by providing manufacturers with a convenient and simple means of reducing the amount of information they must disclose to the public. As long as they are careful with their language and include the quack Miranda, they don’t have to perform clinical trials, they don’t have to prove (or even test) efficacy, and they don’t have to disclose full details of the production process. It can be proprietary.

    Bottom line: companies that manufacture drugs (no matter what names they use to call the drugs, whether “natural” or not) cannot be implicitly trusted. There is far too much potential for abuse. It is therefore folly to remove regulation in the name of health “freedom”. The whole purpose of the regulation is to protect the freedom of us, the consumers. DSHEA doesn’t protect our freedom; it protects the freedom of drug companies. Yes, even the big guys. Big Pharma is more involved in herbal medicine than people realize, and they *love* DSHEA.

  12. #12 Dianne
    July 21, 2009

    PectaSol is Modified Citrus Pectin. Supplement companies are allowed to quote from the scientific literature. Several clinical studies have shown that MCP can slow down the doubling time of PSA: http://www.medicalnewstoday.com/articles/82455.php

    This link didn’t work for me but a medline search showed a single clinical study on a total of 13 men with prostate cancer. Of the 10 who were evaluable for efficacy, 7 had a slowing of PSA doubling time. Not a cure, not a decrease in symptoms, not even a decrease in the PSA, just a slowing of doubling time. Nor was the treatment side effect free: three patients withdrew because of side effects including GI distress.

    This was a heavily pre-treated population and a phase III trial to confirm the effect-and see if it is correlated with any clinically meaningful effects such as regression of lesions or decrease in symptoms– might be interesting but it is by no means ready for sale to the public.

  13. #13 Denice Walter
    July 21, 2009

    Ironically, some woo-meisters actually wear the Quack Miranda as a badge of honor:”Now, we’re not *allowed* to tell you what this product *really* does because”- explaining that the corrupt Gov’mint, which kow-tows to the will of evil Big Pharma,does not allow fine, decent natural health “scientists” to “tell the Truth” and publish their “untainted” research, which of course,would decimate said Big Pharma’s huge ill-gotten profit margins,cure cancer,allow people to double their lifespans, and certainly banish autism,AIDS, and mental illness from the face of the earth.Oh, and they use code words like “Immunity” to signify “anti-cancer”.(BTW, I could never figure out what is so *natural* about swallowing a handful of manufactured supplements and drinking some bizarrely-colored powdered drink-mix instead of eating,er, you know, food.)

  14. #14 Linden
    July 21, 2009

    Reports about supplements from the media are often times very biased and unsubstantiated. This makes finding the TRUTH about how they can help improve your healthy very hard to find. We believe the Dietary Supplement Health and Education Act of 1994 to be one of the single most important events to happen for health freedom. That is why we believe in protecting and defending DSHEA.

    The FDA and FTC continue to censor and engage in heavy-handed attempts to restrict access to supplements and educational information. FDA also continues to prohibit distribution of scientific articles and publications to consumers regarding the role of nutrients in protecting against disease. The FTC actively censors truthful health claims by requiring supplement manufactures to satisfy an unobtainable standard of proof that a health claim statement is true.

    The real issue with dietary supplements is that FDA and FTC isn’t allowing the public vital scientifically based information about them to be known. While the FDA forces natural remedies to jump through hoops they allow huge drug companies, such as Merck, to sell FDA approved medicine that ends in death or serious injury on a regular basis.

    Click on the link bellow to be taken to the American Association for Health Freedom’s page and learn more about this issue. You can even take action!

    http://www.healthfreedom.net/index.php?option=com_content&task=view&id=150&Itemid=179

  15. #15 Dianne
    July 21, 2009

    FDA also continues to prohibit distribution of scientific articles and publications to consumers regarding the role of nutrients in protecting against disease.

    Really? Do give some examples, this is a fascinating statement.

  16. #16 Joe
    July 21, 2009

    @ Jeff, you need to read “Natural Causes” by Dan Hurley (Broadway Books, 2006). The title refers to the harm (including death) caused by “natural supplements.”

    There was a form of adverse-events reporting 20 years ago: it was the many law suits brought against manufacturers of ephedra for heart attacks and strokes (some fatal). The manufacturers preferred to settle out of court rather than concede the “supplement” did more harm than good. Under DSHEA, it took the FDA a long time (and cost many lives) before they amass the data to get ephedra banned. A proper system would have prevented it from being marketed.

  17. #17 Carol M. Magnuson
    July 21, 2009

    I am stunned and amazed by your ignorance, and the vitriolic voice you’ve used.

    What I’d really like to know is: Which Big Pharma interest has paid you for your incredibly uninformed article?

    By law, natural products MUST include what you call the “quack disclaimer.” This is because, by law they are NOT DRUGS.

    By law, ONLY DRUGS can treat, cure, prevent, or mitigate disease.

    By law, natural products companies ARE NOT ALLOWED to cite scientific studies or clinical trials.

    By law, natural products companies ARE NOT ALLOWED to make claims regarding the true efficacy of their products for medical conditions (“diseases”). Those who do, do so purely out of ignorance of the law, not as a means to “line their pockets.”

    It is absolutely ILLEGAL to state the true use of a nutraceutical medicine. These companies CANNOT even IMPLY what their products can do.

    According to a recent AMA (that’s the American Medical Association) report, more than 106,000 people DIE, EVERY YEAR from the use of pharmaceuticals. The only people who die from the use of nutraceuticals, are those who mix pharmaceuticals with nutraceuticals.

    The vast majority of natural product/dietary supplement/nutraceutical companies conduct extensive studies, trials, etc. on their products before bringing them to market.

    I am totally disgusted with people like you who spout false and misleading information about natural medicines which are vastly safer and more effective than chemically-derived, lab-created pseudo medicines which do more harm than good.

    I suggest you make a small effort to educate yourself before you open your “mouth” to us “ignorant masses.” Unfortunately, for you and all others like you, we are not nearly as ignorant as you hope and wish we were.

    Since you are such a loyal proponent of the pharmaceutical industry, I wonder how well you sleep at night, knowing the damage, the pain and the suffering people are experiencing from Big Pharma’s products.

    Or, maybe you’re ignorant about that, as well? Oh well. They do say “ignorance is bliss.” Are you feeling blissful?

    Sweet dreams,

    Carol Magnuson

  18. #18 Igor
    July 21, 2009

    “It is absolutely ILLEGAL to state the true use of a nutraceutical medicine. These companies CANNOT even IMPLY what their products can do.”

    How can you accuse PAL of being uninformed when you make such an ignorant statement after he listed verbatim all the claims PectaSol makes on their website EXPRESSLY stating what their product does. Of course an initial search on CAM practitioners reveals a multitude of claims (some more unreasonable than others) as to what their products supposedly do. Are you ignorant or just a liar?

  19. #19 LanceR, JSG
    July 21, 2009

    I’ve got a free moment, so let me break down Carol’s “argument” by paragraph:

    Ad hominem combined with whining about “tone” – never a good start.

    Pharma shill gambit.

    Lie. They must have that warning because they have not been tested.

    Lie. Anything can treat disease. If it works, it becomes mainstream medicine. If it doesn’t work, slap the Quack Miranda on the label, and sell it anyway.

    Lie. If there were any studies that supported the claims, they would trumpet them to the heavens. If it works, etc.

    Bold lie. And what the f**k is “nutraceutical”? These companies can say anything they like. That’s why the Quack Miranda label is there. That’s part of the problem.

    Wow. Drugs with *actual effects* sometimes cause bad effects. That’s shocking. And I don’t think your numbers are accurate.

    Lie. Most of these supplements have never been tested, or have completely failed testing. It is cheaper for these companies to slap the label on and sell crap than it is to actually test the products.

    False difference. There is no real difference between “natural” products and “chemically-derived, lab-created” ones.

    Ad hominem.

    Restate the Pharma Shill gambit.

    Ad hominem.

    False blessing.

    Total actual content? Zero.

  20. #20 Igor
    July 21, 2009

    not to mention the inanity of the statements like this one?

    “By law, ONLY DRUGS can treat, cure, prevent, or mitigate disease.”

    I’m not aware of any law giving the drugs such power. From the sound of it, the pharmaceuticals derive their effect from operation of law. If only they passed something outlawing heart disease.

  21. #21 Calli Arcale
    July 21, 2009

    Ms Magnuson, makers of “natural” remedies are not forbidden from publishing studies — which is good, because they often do, though they’re not always any good, and not always easy to find, though the manufacturers are seldom shy about citing them — even if they aren’t relevant. (Consider Airborne’s “study”, which was published in the same sense that the Islington planning commission put the plans to demolish Arthur Dent’s house on display.)

    Indeed, the only way your claim can be sort of true is by conceding that supplement manufacturers are not permitted to make medical claims without first proving them to be true. File a new drug application, go through all the same testing that everybody else has to, and you can make those claims to your heart’s content. It’s not our fault the “natural” folks aren’t interested in actually finding out if the stuff actually works.

    LanceR

    And what the f**k is “nutraceutical”?

    My mind may be in the gutter, but I always think of “Neuticles” when I read that word.

  22. #22 Supplement fan
    July 21, 2009

    Why do you liberals want total control of everything. If you don;t take supplements, then shut up and let those of us who do take them, use them in peace. We do not bother you about what you take, why do you bother us? I have releaed some supplement information on my on blog and am taking supplements for weight loss right now. We will have to depend on herbs and supplements after Obama destroys our nation and feeds us national socialism and we are denied healthcare. Get ready, becuase change is coming. Change for the worst that is. http://robhood.us/weblog.php

  23. #23 LanceR, JSG
    July 21, 2009

    Wow. The crazy is strong in this one…

    “You liberals…” Who said anything about liberals? This is not a liberal/conservative issue. If anything, liberals are generally *more* likely to use supplements and be attracted to the whole “natural” woo.

    “If you don’t take supplements…” Right. Just shut up and let them poison us with toxic supplements. Sure. That’s working great for all the Zicam users, isn’t it?

    Vague rant about Obama… you need to find out what “socialism” really means. A vast number of us are already “denied healthcare”. Only it ain’t the government doing the denying, now is it?

    It’s been said a billion times: if it works, it becomes medicine. If it don’t work, slap a vague label on it, and sell it anyway.

  24. #24 Calli Arcale
    July 22, 2009

    Supplement fan: I’m not a liberal. I’m a moderate, usually trending towards conservative. I don’t want total control of everything; I just don’t like the idea of some big private multinational corporation with no accountability having control over what I put into my body. The only way I can have control over them is through my elected representatives. Hence the FDA.

    I do like how you say that you are a user of supplements, then try to scare us by saying that after Obama “destroys” our nation we’ll all only have supplements. Like we should accept supplements as safe and effective but be afraid of being forced to rely on them?

    Of course, I shouldn’t expect consistency from someone who thinks letting private corporations decide our fate is better than having elected representatives decide it. I suppose you would’ve been happy with being imposed taxes arbitrarily by the crown, back in 1775 or so.

  25. #25 Jeff
    July 22, 2009

    Joe:@ Jeff, you need to read “Natural Causes” by Dan Hurley (Broadway Books, 2006). The title refers to the harm (including death) caused by “natural supplements.”

    Joe, Hurley’s book is a joke. It’s hard to keep a straight face reading a book with so many innacuracies.

    In the book and an essay authored by Hurley in the January 16th, 2007 edition of the New York Times, the author claims that:

    The AAPCC database has recorded 1.6 million reports of ‘adverse reactions’ to supplement products (vitamins, minerals, essential oils, herbal products, homeopathic products, etc.) from 1983 to 2005.

    Firstly homeopathic products are NOT supplements and are not covered by DSHEA. It was soon realized that Hurley had counted all “exposure calls” as adverse reactions. Exposure calls are non-administrative, non-information calls; the caller was concerned about an exposure to a substance. Typically only about 10 percent of these result in adverse reactions (requiring medical attention). He was inflating the adverse reaction calls BY A FACTOR OF TEN. When confronted with the truth the NYT had to print a retraction on Feb. 6, 2007. Unfortunately the inflated number remains in the book, and people love to quote it as proof how “dangerous” supplements are.

    Mr. Hurley writes about a woman who claims her nose fell off after applying a product meant to treat what she thought was skin cancer. Any medicinal, topically applied product that squeezes out of a tube does not remotely resemble a dietary supplement. Yet he uses this phony example to slam all dietary supplements.

    These are just two examples. There are others.

    If you want accurate information about supplements, try Byron Richards’ website:
    http://www.wellnessresources.com/health_news_views

  26. #26 LanceR, JSG
    July 22, 2009

    And teh WooWarz continue! It’s all well and good for all “Natural Remedies” to be grouped together in happy times, but let one Zicam or “black tar” problem arise and it’s “No True Scotsman” all over.

  27. #27 Supplement fan
    July 22, 2009

    “A vast number of us are already “denied healthcare”. Only it ain’t the government doing the denying, now is it?”

    ————–

    The whole “47 million americans do not have health insurance” is a lie. at least 10 million of them are illegal aliens. So now we subtract that and end up with 37 million uninsured. But wait a minute. There are those in the age range of 18-35 who are offered health insurance at work who CHOOSE NOT TO PARTICIPATE!. Stop believeing left wing fascist control propaganda from the government.

    I personally work with people who are offered insurance at the same rate that I pay ($38.00 per week) who choose of their own free will to participate and then fuss about medical bills and doctor visits. That is plain stupidity. They take their little brats to the health department and guess who has to pay for that? You guessed it – ME! Why should I have to pay for my own healthcare and someone else’s too? That is not right.

    In my opinion, if we are oing to have universal socialism, or Obamacare, then we should have the choice to not have to pay into the system if we are not using the system coverage. Is that too much to ask?

    Also if we cut off funding to PBS, ACLU, Planned Parenthood, oversease abortions, the UN and all other unnecesary programs we would have plenty of money to fund Social Security and Medicare. Idiots in Washongton don;t know to run anything except their mouth. I hate fascist left wing swine (the government).

    As far as I’m concderned, I’ll be glad when that asteroid hits washington.

  28. #28 LanceR, JSG
    July 22, 2009

    Ah, now we get to the *real* root of the matter.

    Why should I have to pay for my own healthcare and someone else’s too?

    You.
    Already.
    Are.

    Every single person who has no insurance or inadequate insurance makes you pay more. Every time someone puts off dealing with a chest cold until it develops into pneumonia, you pay more. Every infected cut that turns into septicemia, costs you more. Every unvaccinated child who spreads illness through a community, costs you more.

    That is the real root of the problem. We in America pay more per capita for health care than any other industrialized nation. And we get *worse* results.

    Read a book. Put down the remote, turn off Faux News, and learn how the world really works. Quit ranting about ObamaCare, and learn how well Medicaid/Medicare really work. (Or would if they were adequately funded). Supplements aren’t going to help you.

  29. #29 Jeff
    July 23, 2009

    One more example from Dan Hurley’s book, Natural Causes:

    The author writes an entire chapter on the amino acid Tryptophan. When the FDA banned Tryptophan in 1989 it was because of problems caused by a single tainted batch made by one Japanese company. Up to that point Tryptophan was one of the most popular supplements sold in the US. It is very useful for treatment of insomnia, depression, and obesity. It is also very inexpensive since it occurs naturally and can’t be patented. For decades Tryptophan has been included in baby formula–If there had been any problems with Tryptophan itself we would have known about it a long time ago. Hurley tries to convince us Tryptophan is intrinsically harmful. He hints vaguely at a conspiracy to suppress corroborating research. The result: Recently, in the face of overwhelming evidence of Tryptophan’s safety, the FDA finally allowed it back on the US market!

    The only way Dan Hurley can make his fear-mongering case against supplements is by distorting facts and figures.

    The Ephedra situation was tragic for the victims and a public relations disaster for the supplement industry. The problem could have solved if the FDA had mandatory recall authority. Let’s give it that authority. Of course with the new GMP rules (see post #2) mandatory testing would probably have prevented any contaminated Tryptophan from being sold.

    In the meantime let’s keep DSHEA. Dietary supplements are safe and affordable. Valid, well-designed studies come out every month demonstrating supplements are beneficial to health.

  30. #30 LanceR, JSG
    July 23, 2009

    Valid, well-designed studies come out every month demonstrating supplements are beneficial to health.

    Name three.

  31. #31 Jeff
    July 23, 2009

    To LanceR:

    1. This latest study showed that intake of high levels of both carotenoids and antioxidants preserved the macular pigments, slowing down the progression from early AMD to late AMD. In contrast, the macular pigments of participants in a placebo group declined steadily:
    http://www.sciencedaily.com/releases/2009/06/090619082129.htm

    2. A new study shows that infants aged 3 – 24 months have better growth when they consistently take a multivitamin every day at the dose of 100% – 150% of the recommended daily allowance (daily value on the supplement facts panel). This study should come as no surprise, as nutrients are obviously needed to facilitate millions and millions of healthy chemistry reactions on a daily basis. Any young child is in the rapid growth mode and being short on needed nutrients has an adverse effect on optimizing genetic potential during this crucial growth time:
    http://www.wellnessresources.com/studies/entry/infants_growth_and_mutli_vitamins

    3.Resveratrol is at the forefront of supplement research due to its powerful ability to activate sirtuins in the nucleus of the cell, key gene signals involved with cell survival. Interestingly, higher doses of resveratrol also help kill cancer cells. The excitement is permeating the scientific world, as can be seen in the comments from authors of a recent review on resveratrol:
    http://www.wellnessresources.com/health/articles/resveratrol_continues_to_impress/

    4. Women receiving a combination of vitamins C and E, and exercise did not experience any bone loss during a six-month period, while women receiving placebo did experience detrimental bone loss, according to findings published in Osteoporosis International:
    http://www.nutraingredients-usa.com/Research/Antioxidants-plus-exercise-may-boost-bones-in-older-women

    I chose these four because they are human studies. There are also many cell studies and animal studies:

    5. Cataracts occur when the structural proteins of the lens of your eyes begin to form tangles. This occurs over time from some form of stress, such as exposure to sunlight (along with not enough antioxidants to keep up with the free radical damage). A new study with animal lenses shows that carnosine not only reduces the formation of these cataract-forming tangles, it can actually clear them up.:
    http://www.wellnessresources.com/health/articles/carnosine_may_help_prevent_and_reverse_cataracts/

  32. #32 Igor
    July 27, 2009

    2) “We conducted a randomized, double-blind, controlled trial in central Mexico.”

    A placebo group of central Mexican kids, they would’ve hjad even better results if they had a placebo group of Central African kids, but that would’ve been too obvious. Once again, no one is arguing the benefit of supplements in case of a deficiency.

    1) “New Supplement May Help Slow Sight Loss In Elderly”

    Notice the careful language of unreplicated preliminary study. What it doesn’t say is “New study says load up on carotene to prevent eyesight loss.”

    4) “Antioxidants plus exercise may boost bones in older women”

    Ditto.

    It’s too late for an in depth analysis of the rest (don’t get me started on reservatrol)

  33. #33 Jeff
    July 28, 2009

    Igor,
    Are you so sure the diet of infants in central Mexico is so much worse than U.S. infants, especially in low-income areas? Maybe deficiencies are more common than you seem to think:

    1. http://www.nutraingredients.com/Research/Call-to-action-issued-for-raising-vitamin-D-levels

    Recommended daily intakes of vitamin D should be raised to 2,000 International Units, says a group of 18 scientists from the University of California. Previously, experts have noted that about one billion people are estimated to be vitamin D deficient with children and adults in Europe at particular risk, even more so since very few foods are fortified with the vitamin. In adults, vitamin D deficiency may precipitate or exacerbate osteopenia, osteoporosis, muscle weakness, fractures, common cancers, autoimmune diseases, infectious diseases and cardiovascular diseases. There is also some evidence that the vitamin may reduce the incidence of several types of cancer and type 1 diabetes, said the UC scientists.

    2. http://www.medicalnewstoday.com/articles/145717.php

    Inadequate Micronutrient Status Is More Common Than Expected: European adults and adolescents often do not get the essential vitamins and minerals needed from their diet, even if it is well-balanced. This is the overall consensus shared by outstanding scientists in the field of micronutrient research.

    As for the other two–Researchers always use cautious language. These studies are not the last word on their subjects. Of course more research is needed. But you can’t ignore the RESULTS: In both studies supplements were better than placebo.

    All four of these studies came out in the last few months, which reinforces my initial statement: Studies are coming out every month which show supplements are beneficial to health.

  34. #34 Jeff
    July 28, 2009

    To Igor:
    From the article on using carotenoids for AMD:

    Dr Chakravarthy added: “These findings are important because this is the first randomised controlled clinical trial to document a beneficial effect through improved function and maintained macular pigment.

    BTW this latest study is not the first to find carotenoids effective for the treatment of AMD. There have been others:
    http://www.lef.org/magazine/mag2008/jun2008_Protecting-Our-Eyes-Against-Time-Induced-Damage_01.htm

    It might take many years and several more studies for carotenoids to become an FDA-approved therapy for AMD or cataracts. What we do know is:
    1. Several studies have shown lutein and zeaxanthin are effective in treating AMD.
    2. Both supplements are safe, affordable, and easily avaliable. Since they can’t be patented no pharmaceutical company will pay the enormous cost it would take for FDA approval.

    Let’s say my doctor gives me a diagnosis of AMD. I discover through my own research that carotenoids might help my condition. Unfotunately some doctors believe all supplements are worthless; they firmly believe no supplement could possibly be used to treat anything.

    This is why we need DSHEA. I wouldn’t need my doctor’s permission to try lutein and zeaxanthin for my AMD. I could simply buy them and take them.

  35. #35 LanceR, JSG
    July 28, 2009

    @Jeff: I’m still wading through the studies you listed, so bear with me for a bit…

    Since they can’t be patented no pharmaceutical company will pay the enormous cost it would take for FDA approval.

    This is a recurrent theme in woo circles, and I gotta call bullshit. Most of the supplements on the shelf *are* from the pharmaceutical companies. Vitamins are a *hugely* profitable area, and it wouldn’t take long with our broken patent process for Merck (for example) to patent their own formulation.

    The problem is that the studies have been so hit or miss on any actual benefit.

    Unfotunately some doctors believe all supplements are worthless; they firmly believe no supplement could possibly be used to treat anything.

    Again, I call bullshit. Medicine has understood the need for proper nutrition and the utility of some supplements for many years. What “some doctors” have a problem with is the way every new tabloid story “zOMG! Take Zylitolican or you’ll DIE!” generates a hundred people who insist that Zylitolican will fix their issue, so “I don’t need that blood pressure prescription, doc. I’m taking Zylitolican.”

    A few dozen of those in a week, and it’s understandable that the doctor gets annoyed with the next person asking about “Tolliscanifarct 2.0″

  36. #36 Igor
    July 28, 2009

    “Are you so sure the diet of infants in central Mexico is so much worse than U.S. infants, especially in low-income areas? Maybe deficiencies are more common than you seem to think”

    No, but i would have the same problem with selection of kids from Appalachia in U.S. to test the general health benefits of dietary supplements. Are you saying that vitamin supplements are beneficial for nutrition deprived children in that region? No one is disputing that, but that’s not what you and the authors of the study want us to believe, is it?

  37. #37 Jeff
    July 28, 2009

    LanceR: “Most of the supplements on the shelf *are* from the pharmaceutical companies. Vitamins are a *hugely* profitable area, and it wouldn’t take long with our broken patent process for Merck (for example) to patent their own formulation.”

    Supplements are not a high-margin business. Annual dietary supplement sales total about $24 billion, compared to $500 billion for pharmaceuticals. Let’s say Merck does come up with their own lutein/zeaxanthin formulation. They cough up the $800 million or so to perform all the studies it would take for FDA approval as treatment for a specific disease (AMD). Merck would then have to charge an exhorbitant price for the product in order to recoup their investment. In the meantime anyone could go to Amazon and spend $11 for a one month supply of lutein/zeaxanthin:
    http://www.amazon.com/gp/product/B000Z96K9G/ref=sr_1_4?ie=UTF8&s=hpc&qid=1236997950&sr=1-4

    Merck could patent their own formulation, but they couldn’t patent either lutein or zeaxanthin; these are naturally occurring molecules, already in the food supply.

    To Igor:
    How about this study:

    Multivitamins and minerals help children’s brain function: study:
    http://www.nutraingredients-usa.com/Research/Multivitamins-and-minerals-help-children-s-brain-function-study

    The Newcastle-based researchers, in collaboration with scientists from Swinburne University in Australia, and the University of Westminster in London, recruited 81 children (average age 11) to participate in the randomised, double-blind, placebo-controlled, parallel groups investigation.

    Kennedy and his co-workers report that the children in the vitamin/mineral group performed more accurately on two tests of attention. Indeed, the researchers noted the first signs of improvement only three hours after the first dose on the first day.

    “The most surprising facet of the improvement in attention task performance seen here is that it became evident by three hours post-dose on the first day,” they wrote.

    Or this one:

    Lewin Group Issues Health Impact Studies-
    Indicates Billions Could Be Saved in Health Care Costs through the Use of Selected Supplements:

    http://www.supplementinfo.org/index.php?src=gendocs&ref=lewin_page&category=Lewin

  38. #38 Michael Gederberg
    December 12, 2009

    In response to PalMD’s overall blog (which I find to be a “mockery” of a mockery of a mockery actually, so it is in itself a triple negative and therefore in itself a mockery) and his link to the Quack Miranda Warning and also LanceR’s super-rational response to Carol’s post:

    I am a patient, not a doctor… But I am smarter than the average bear as a patient, sometimes too smart for my own good… I’ve seen how allopathic pharmaceuticals have done miracles for some and harmed or killed other people, some were close to me and some just acquaintances… Many of these treatments, just disconnect the check engine light of symptoms in a patient, period… Is that necessary for acute and life threatening symptoms? Sometimes, yes… Does it always ameliorate the overall problem(s) though? No, not usually… I’ll say this as a patient, I intuit that within 10 years everything we THINK we know now about medicine will be proven to be a LIE! The art of medicine in my opinion has just about been LOST, everyone’s a pill pusher for profits… No fault of their own, other than laziness perhaps, replacing assumptions for questions and innovation…

    Now anybody with a brain reading what PalMD has blogged about, might on one hand accept what he is saying about the sinister aspect of his perspective of the “truth”… Sure the DSHEA requires supplements to label themselves with the fine print:
    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

    However, there’s an awful lot of fine print and disclaimers with pharmaceuticals too… Every other damn commercial on TV about some new drug, states it might do this or that or kill you and see your doctor right away if you have any of the symptoms… Care to amend your “truth”? I think yeah there is either a witting or unwitting “conspiracy” as this bastard puts it, yet PalMD goes so far as to say to think so, one is bat shit crazy for believing so… And so I ask the super-rational LanceR, is this not an ad hominem attack also? Essentially folks, it does come down to money, the multinational pharmaceutical corporations can afford to spend loads of it on the research to back up and spin what their drugs do or do not do… They might even throw some of that cash at propaganda to defame other modalities of treatment and care… Is PalMD perhaps a mole or pied piper for them? I honestly don’t know, that’s on his conscience, not mine… It all comes down to an individual’s freedom to choose and this what is great about our great nation…

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